Regulatory approval

Published by the Health Service Executive. Approved

Nivolumab in combination with fluoropyrimidine and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER-2 negative advanced or metastatic gastric (GC), gastroesophageal junction cancer (GEJC) or esophageal adenocarcinoma (EAC), whose tumours express PD-L1 (CPS) >= 5.

This is written in the approval document.

Reimbursement

Incomplete Reimbursement

Nivolumab - ODMS; Oxaliplatin, 5-Flourouracil - N/A

Citation

Nivolumab and FOLFOX-6 Modified Therapy, 2026, version number 3a, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6445/844_Nivolumab_FOLFOX6_.pdf

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	HER2-negative, PD-L1 (CPS) >= 5	Esophageal Adenocarcinoma	Fluorouracil, Nivolumab, Oxaliplatin
HSE (1)	HER2-negative, PD-L1 (CPS) >= 5	Adenocarcinoma of the Gastroesophageal Junction	Fluorouracil, Nivolumab, Oxaliplatin
HSE (1)	HER2-negative, PD-L1 (CPS) >= 5	Stomach Adenocarcinoma	Fluorouracil, Nivolumab, Oxaliplatin